BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUACEL FOAM

    MDR report key: 3884084 · Received June 9, 2014

    Report

    Report Number
    1049092-2014-00187
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    NAC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY BASED ON THE REPORTS THAT MEPILEX IS CONSIDERED AS MEDICAL TREATMENT BECAUSE THE MEPILEX DRESSING WOULD BE ORDERED/PRESCRIBED BY A PHYSICIAN. COMPLAINANT HAS CONFIRMED THAT PRODUCT LOT NUMBER IS NOT AVAILABLE AND THAT THE LOT NUMBER IS NOT RETRIEVABLE. NO SAMPLE WAS AVAILABLE FOR EVAL; HOWEVER, AN INVESTIGATION WAS PERFORMED ON (B)(6) 2014 BY THE THIRD PARTY MFR, (B)(4), BASED ON THE REVIEW OF DEVICE HISTORY RECORDS, STERILIZATION RECORDS, AND RETAIN SAMPLES OF THE TEN (10) PREVIOUS PRODUCTION PATCHES. RESULTS SHOWED NO NON-CONFORMANCES DURING THE MFG, PACKAGING AND STERILIZATION PROCESSES AND NO EVIDENCE INDICATED A MFG ERROR OCCURRED. ALL RAW MATERIALS WERE RECEIVED WITH THE SUPPLIERS CERTIFICATE OF CONFORMANCE AND/OR CERTIFICATE OF ANALYSIS AND THE AQUACEL FOAM IS REPORTED TO HAVE BEEN MANUFACTURED USING MEDICAL GRADE RAW MATERIALS THAT HAVE BEEN APPROVED FOR SKIN CONTACT UNDER CGMP CONTROLLED CONDITIONS IN AN (B)(4) STATES THAT THERE IS NO EVIDENCE TO INDICATE A MFG ERROR HAS OCCURRED AND OCCASIONAL ALLERGIC REACTIONS HAVE BEEN NOTED TO PRODUCTS CONTAINING SILICONE ADHESIVES. PRODUCT LOT NUMBER IS NOT RETRIEVABLE. IN CONCLUSION, THIS IS PART OF (B)(4) CAPA SYSTEM AND THEY HAVE INDICATED THEY WILL CONTINUE TO MONITOR FOR ANY INDICATION OF REPEATABLE RECORDS BY COMPLAINT TYPE AND PRODUCT NUMBER, AND WILL REVIEW THE DATA TO EVALUATE TRENDS RELATING TO CUSTOMER COMPLAINTS. REPORTED TO FDA ON (B)(6), 2014. NOTE: THE ACTUAL DATE OF EVENT IS UNK, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE. CONVATEC WILL CONTINUE TO TRACT AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S. COMPLAINT HANDLING AND CAPA PROCEDURES.

    Description of Event or Problem · 1

    IT IS REPORTED THAT TWO (2) PTS DEVELOPED IRRITANT DERMATITIS FOLLOWING THE USE OF AQUACEL FOAM DRESSING IN THE HOME SETTING. THE PT(S) DEVELOPED RED AND OPEN SKIN UNDER THE DRESSING. THE DRESSING WAS DISCONTINUED AND THE REDNESS RESOLVED WITH THE USE OF A MEPILEX DRESSING. PLEASE NOTE: THERE ARE TWO (2) PTS WHO DEVELOPED IRRITANT DERMATITIS. THIS REPORT REPRESENTS PT #1 OF #2, AND IS RELATED TO PT IDENTIFIER# (B)(6), AND MFG REPORT# 1049092-2014-00189.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335329 AQUACEL FOAM HYDROPHILIC WOUND DRESSING, 79 NAC NAC CONVATEC INC. 420619 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention